A Phase 3 interventional study of Topical lidocaine and Nebuliser solution in Bronchiectasis Adult, Mediastinal Lymphadenopathy and Pneumonia, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Milton S. Hershey Medical Center · Phase 3, Interventional, and Treatment
The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 29 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.
Drug: Topical lidocaine
2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.
Drug: Nebuliser solution
2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.
Drug: Nebuliser Suspension
1% lidocaine topically applied in 4 mL aliquots
Also known as: Topical
2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
Also known as: Nebulizer
2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
Also known as: Atomizer
Cough
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
Time frame: 1 day
Number of Participants With Post-procedure Sore Throat
sore throat was self reported by patient as: none, mild, moderate, severe
Time frame: 1 day
Number of Participants With Post-Procedure Subjective Cough
Subjective cough as described by patient as: none, mild, moderate, severe
Time frame: 1 day
Anesthesia Time to Wake up
time in minutes from scope out until ready for transport to post anesthesia care unit
Time frame: 1 day
Alfentanyl Dosing
Total alfentanyl dosing by anesthesia in mcg/kg
Time frame: 1 day
Propofol Dosing
Total propofol dosing by anesthesia in mg/kg
Time frame: 1 day
Fentanyl Dosing
total fentanyl dosing by anesthesia in mcg/kg
Time frame: 1 day
Participants will be Identified from pool of patients who will already be undergoing with planned flexible bronchoscopy and/or endobronchial ultrasound by an interventional pulmonologist in the operating room setting. They will be identified by review of the operating room schedule and through the interventional pulmonology clinic.
| Milestone | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| Started | 15 | 7 | 7 |
| Completed | 15 | 7 | 7 |
| Not completed | 0 | 0 | 0 |
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
| coughs | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| Cough | 1.20 ± 1.70 | 1.71 ± 1.60 | 1.00 ± 1.00 |
sore throat was self reported by patient as: none, mild, moderate, severe
| Participants | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| none | 6 | 4 | 2 |
| mild | 4 | 0 | 3 |
| moderate | 1 | 2 | 1 |
| severe | 0 | 0 | 0 |
Subjective cough as described by patient as: none, mild, moderate, severe
| Participants | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| none | 1 | 1 | 2 |
| mild | 8 | 4 | 3 |
| moderate | 2 | 1 | 1 |
| severe | 0 | 0 | 0 |
time in minutes from scope out until ready for transport to post anesthesia care unit
| minutes | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| Anesthesia Time to Wake up | 8.47 ± 4.02 | 13.00 ± 5.77 | 6.14 ± 3.80 |
Total alfentanyl dosing by anesthesia in mcg/kg
| mcg/kg | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| Alfentanyl Dosing | 16.61 ± 22.64 | 47.99 ± 37.41 | 4.40 ± 7.42 |
Total propofol dosing by anesthesia in mg/kg
| mg/kg | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| Propofol Dosing | 5.30 ± 3.23 | 6.93 ± 3.36 | 3.26 ± 0.81 |
total fentanyl dosing by anesthesia in mcg/kg
| mcg/kg | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
|---|---|---|---|
| Fentanyl Dosing | 0.30 ± 0.28 | 0.24 ± 0.23 | 0.48 ± 0.39 |
Collected over Data collected in the post-anesthesia care unit up to 1 hour after procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topical Lidocaine | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Nebuliser Solution | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Nebuliser Suspension | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
|---|---|---|---|---|
| Mean | 66.80 ± 12.81 | 55.57 ± 16.83 | 57.43 ± 14.77 | 61.83 ± 14.75 |
| Sex: Female, Male(Participants) | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
|---|---|---|---|---|
| Female | 7 | 3 | 4 | 14 |
| Male | 8 | 4 | 3 | 15 |
| Race (NIH/OMB)(Participants) | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 15 | 6 | 6 | 27 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
|---|---|---|---|---|
| United States | 15 | 7 | 7 | 29 |
| BMI(kg/m^2) | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
|---|---|---|---|---|
| Mean | 30.19 ± 6.93 | 29.39 ± 4.84 | 28.53 ± 8.23 | 29.59 ± 6.63 |
| Smoking History(Participants) | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
|---|---|---|---|---|
| currently smoking | 4 | 3 | 1 | 8 |
| quit smoking | 7 | 2 | 2 | 11 |
| never smoked | 4 | 2 | 4 | 10 |
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Milton S. Hershey Medical Center